Sealantium Medical has completed the enrolment of 32 patients to its randomized, open-label, comparator Phase I/II clinical study at four centers in the EU and the U.S. The study is evaluating the safety and efficacy of its flagship product, sFilm-FS, versus TachoSil, the market leading product, in controlling liver bleeding.
Data from an interim analysis suggest that sFilm-FS™ is safe and effective. Final data is expected 3Q23.
Pivotal Ph III studies are expected to start 4Q23.
